Acupuncture is gaining wide acceptance as a medical treatment for a variety of health conditions, and has become widely integrated into health care systems throughout North America. By way of general overview, acupuncture involves the insertion of a filiform needle (at least the shaft of which is typically constructed of medical grade stainless steel) to a target depth below the dermis of the skin at a predetermined sensitive point, and the performance of various additional procedures selected to stimulate a positive change in the health condition of a patient. These additional procedures may, for example, involve heating the needle with a heat source (commonly known as “moxibustion”), applying electrical stimulation to the needle, such as by attaching the needle to a milliamp or microamp stimulator, and/or the use of various manual manipulative techniques such as thrusting, angling and vibrating the needle.
To minimize patient discomfort, the acupuncture needle is typically first quickly “set” through the dermal layer of the patient's skin, and then further inserted through the skin into the body of the patient to a target depth of up to several centimeters, depending upon the application and on the region of the body being treated. In many cases, the acupuncture treatment may be preformed on a recumbent patient that has been positioned so as to facilitate the practitioner's access to the predetermined sensitive point. However, in some instances, such as when patients have circulatory or neurological limitations, this is not possible and the acupuncture needle must be set and inserted horizontally, or even from below.
Great care must be taken to maintain sterility of the acupuncture needle throughout the entire acupuncture treatment process in order to protect both the patient and the practitioner from possible contamination, and acupuncture needle delivery techniques have accordingly evolved over the years from simple free hand insertion and manipulation to the use of insertion tube-assisted delivery systems intended to assist with the maintenance of sanitary conditions (and in some instances to facilitate consistent setting of the acupuncture needle). As is discussed further below, the use of an insertion tube surrounding the needle shaft facilitates sanitary pre-use initial handling and setting of an acupuncture needle by a practitioner. Once the needle has been set, the insertion tube is generally discarded in order to permit the further insertion and manipulation of the needle at the target depth.
Additional sanitary challenges often arise, however, during the further insertion and manipulation of the acupuncture needle at the target depth, particularly in situations where the practitioner is inserting the needle into scarred, dense, or fibrous tissue (such as in intra-articular insertions in, for example, the knee). In these situations and others, such as where, for example, the needle has a thickness of 0.22 mm or less and a needle length is 35 mm or shorter, or a thickness of 0.22 mm or greater and a length that is 50 mm or longer, the needle is prone to bowing or bending during further insertion and manipulation.
Any such bowing or bending interferes with the practitioner's ability to accurately insert and manipulate the needle, and requires the practitioner to attempt to compensate by initiating time consuming and/or difficult compensatory movements. In many cases, suitable compensation for the bowing or bending of the needle is not easily achievable, and in some cases may not be achievable at all by even the most skilful practitioner unless the practitioner stabilizes the shaft of the needle using a cotton swab or simply his/her fingers. These stabilization techniques compromise the sterility of the needle, and increase the risk of infection.
To address this need for stabilization (and the resulting potential for contamination), acupuncture needle assemblies and delivery systems that additionally provide a grip element have been proposed. However, all known acupuncture needle assemblies and delivery systems that additionally provide a grip element to facilitate stabilization of the needle during insertion and manipulation fail to adequately address the need for such stabilization when the needle is inserted horizontally or from below the predetermined sensitive point, or fail to adequately accommodate the performance of various stimulative procedures. In addition, many of the known needle assemblies and delivery systems are relatively difficult to manufacture and to use.
By way of example, U.S. Pat. No. 5,624,460 to Yoo describes an acupuncture needle assembly that includes a “guide pipe” (i.e. an insertion tube) and a paper, rubber or foamed resin “grip pipe” that is located within the guide pipe and that immediately surrounds the needle shaft about 3-5 mm from the end portion of the needle head. As with a conventional insertion tube-assisted delivery system, the guide pipe facilitates the sanitary pre-use initial handling and setting of the needle, and is discarded once the needle has been set. A practitioner may then grasp the grip pipe to stabilize the needle during the acupuncture stimulus, and use the grip pipe to withdraw the needle from the patient after use.
However, since the Yoo grip pipe is formed of paper, rubber or foamed resin, and since it immediately surrounds the shaft of the needle, which has an internal diameter that is smaller than that of the handle or upper “grip portion” of the needle itself, the Yoo grip pipe cannot readily be removed from the needle during use, and would accordingly impede procedures requiring a practitioner to heat or electrify the needle. For example, the moxibustion technique known as “sparrow pecking” requires a practitioner to heat the acupuncture point and needle with an external heat source to stimulate circulation and immune function. It is important in performing this technique to bring the heat source to the point were the heat is intense but tolerable in a “coming and going” process (i.e. in a “pecking” manner), and to achieve this the heat source must be brought as close as possible to the needle and to the skin to generate a strong heat reaction. Since the Yoo grip pipe is immediately associated with the needle shaft and cannot readily be removed, it may have an insulatory effect between the needle and the heat source (and may itself melt or burn if brought too close to the heat source), and thereby limit the effectiveness of this type of procedure. Additionally, in some scenarios, the treatment target depth may require the needle to be inserted up to 90% or so of it's overall length. Since the Yoo needle assembly does not provide for removal of the grip pipe during use, the grip pipe also limits the depth to which a practitioner may insert the Yoo needle.
Published U.S. patent publication Ser. No. 11/292,025 to Teichert et al. (U.S. Patent Publication No. 2007/0129744), the disclosure of which is hereby fully incorporated by reference, describes an acupuncture needle guide assembly that comprises an acupuncture needle with a shaft and a needle handle, a guiding tube (i.e. an insertion tube) accommodating the acupuncture needle before use and providing guidance for setting the acupuncture needle, a holding tube being arranged within the guiding tube and providing a cover for the needle shaft, and a destructible or detachable connector fixing the holding tube between the needle handle and an inner wall of the guiding tube until the connector is removed or broken. The holding tube has an inner diameter that is greater than the diameter of the needle shaft, and preferably has an inner diameter that is greater than the outer diameter of the needle handle in order to permit the holding tube to be removed from the needle after insertion thereof into the body. In use, the assembly is first positioned on the skin of the patient to be treated, and the acupuncture needle is then released by removing or breaking the connector. Upon removal or destruction of the connector, the holding tube drops down the shaft of the needle towards the tip thereof under the effect of gravity, and is manually gripped by the practitioner after the guiding tube is withdrawn to facilitate stabilization during the further insertion and manipulation of the needle.
Although the “loose” fit of the holding tube vis-à-vis the needle of the Teichert et al. assembly permits the holding tube to be removed during use and thereby addresses some of the shortcomings of the Yoo assembly, the inability of a practitioner to control the position of the holding tube after the connector is removed or broken, but prior to removal of the guiding tube, makes it generally unsuitable for use in horizontal orientations, or in situations where the needle must be set and inserted from below the predetermined sensitive point.
There accordingly exists a need for an improved acupuncture needle and delivery system that facilitates the sanitary insertion and handling of the acupuncture needle in all orientations, and that does not impede the performance of the various post-insertion procedures of the sort that are commonly used by acupuncture practitioners to stimulate a positive change in the health condition of a patient. Since the need for stabilization of the needle shaft is situation dependant, provision of an improved acupuncture needle and delivery system in which the implementation of the stabilizing feature is optional and does not commit the practitioner to a predefined insertion process would also be beneficial.